PMDA drug package insert

プレガバリンカプセル25mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Sep 11, 2025

Key facts

Brand names プレガバリンカプセル25mg「サワイ」, プレガバリンカプセル75mg「サワイ」, プレガバリンカプセル150mg「サワイ」, プレガバリンOD錠25mg「サワイ」, プレガバリンOD錠75mg「サワイ」, プレガバリンOD錠150mg「サワイ」
Nonproprietary names プレガバリン
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 疼痛治療剤(神経障害性疼痛・線維筋痛症)
Therapeutic category codes 871190
YJ codes 1190017M1036, 1190017M2032, 1190017M3039, 1190017F1150, 1190017F2157, 1190017F3153
Approval numbers 30200AMX00859000, 30200AMX00860000, 30200AMX00861000, 30200AMX00862000, 30200AMX00863000, 30200AMX00864000
Package insert edition 第2版
Package insert date Sep 11, 2025
PMDA document key 300119_1190017F1150_1
PMDA company code 300119

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • No PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

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